SmartSurgN Visualization System

Q: What is the product code of K213943?

The FDA product code is OWN – Confocal Optical Imaging, a Class II (moderate risk) device regulated under 21 CFR 876.1500.

FDA 510(k) K213943 · Smartsurgn Incorporated

Substantially Equivalent

510(k) numberK213943

Submission

Device name: SmartSurgN Visualization System
Applicant: Smartsurgn Incorporated
San Jose, CA, US
Received: December 17, 2021
Decision date: November 29, 2022
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: OWN – Confocal Optical Imaging
Device class: Class II (moderate risk)
Regulation: 21 CFR 876.1500
Specialty: Gastroenterology, Urology

Collection of light signals for visualization of cellular microstructures.

Other 510(k)s with product code OWN

510(k)	Device	Applicant	Decision
K254180	PerfusiX-ImagingOWN · Traditional	LIMIS Development B.V.	07/24/2026SE
K242163	SmartSurgN Visualization SystemOWN · Traditional	SmartsurgN, Inc.	04/20/2026SE
K254242	KARL STORZ ICG Imaging System with RUBINA® LensOWN · Traditional	Karl Storz SE & CO. KG	02/26/2026SE
K251852	cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200)OWN · Traditional	VPIX Medical, Inc.	02/13/2026SE
K260108	L12 LED Light Source with AIMOWN · Special	Stryker Endoscopy	02/12/2026SE
K253972	IMAGE1 (TC400US); X-to-4U Adapter (TC040)OWN · Traditional	Karl Storz SE & CO. KG	02/12/2026SE
K251336	VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700); VISERA ELITE III Light…OWN · Traditional	Olympus Medical Systems Corp.	11/12/2025SE
K243711	Confocal Microprobe Imaging System (BrightP980); Confocal Microprobe Imaging System…OWN · Traditional	Wuxi Hisky Medical Technologies Co., Ltd.	07/24/2025SE
K243591	OPTOVISION Endoscopic Light Source UnitOWN · Traditional	Optosurgical, LLC	02/19/2025SE
K241275	Histolog® Scanner (Hardware 2.4, Software 3.3)OWN · Traditional	Samantree Medical SA	08/19/2024SE

More from Samantree Medical SA

510(k)	Device	Decision
K242163	SmartSurgN Visualization SystemOWN · Traditional	04/20/2026SE
K242772	AirSurgN Insufflator (10030/AirSurgN)HIF · Traditional	04/11/2025SE

Questions and answers

When was SmartSurgN Visualization System cleared by the FDA?

SmartSurgN Visualization System (K213943) received a 510(k) decision of Substantially Equivalent on November 29, 2022, 347 days after the submission was received.

What is the product code of K213943?

The FDA product code is OWN – Confocal Optical Imaging, a Class II (moderate risk) device regulated under 21 CFR 876.1500.